The design of a reusable medical device, more so than the particular cleaner or disinfectant, determines how reliably microbes and soil will be removed. Devices that are smooth and relatively seamless can be reprocessed time and time again without issue. Devices with problematic design elements can be nearly impossible to completely clean and disinfect, no matter what detergents and disinfectants are used.
In Microchem’s experience, the following design elements tend to shelter soil and microbes from cleaning and disinfection:
Recessed or exposed hardware such as screw heads
Absorbent or porous surfaces, such as open foams or fabrics
When design components prove during testing to be hiding places for soil and microbes, cleaning and disinfection instructions becomes arduous and instructions for use (IFUs) balloon. Worse, disinfection-resistant, pathogenic biofilms can form in these locations during actual use.
When a reusable medical device shows failures in cleaning and disinfection validation, Microchem works hand-in-hand with clients to identify the problematic sites and propose modifications to IFUs that work.
If your company is designing a reusable medical device that will require reprocessing validation, we’re available for free consultation at any point in the process. For more information on validation testing, please contact Hannah Klug, our Medical Device Testing Team Lead.